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Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

Primary Purpose

Premature Birth of Newborn, Intervention Studies

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Direct swallowing training (DST)
Oral sensorimotor stimulation (OSMS)
Sham intervention
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth of Newborn focused on measuring Infant, Premature, Intervention Studies, Bottle feeding

Eligibility Criteria

22 Weeks - 31 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Preterm infants : before 32+0 weeks gestation
  • Infants who are receiving full tube feeding (more than 120 ml/kg/day)
  • Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks
  • 'Feeders and growers'
  • The parents of the subject voluntarily sign the informed consent

Exclusion Criteria:

  • Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc
  • Gastrointestinal complications
  • Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Experimental

Experimental

Arm Label

Control

DST group

DST+OSMS group

Arm Description

Two 15-minute sessions of sham intervention/day, five days a week

One session of DST and the other of sham intervention/day, five days a week

One session of DST and the other of OSMS/day, five days a week

Outcomes

Primary Outcome Measures

Days from start to independent oral feeding
Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day)

Secondary Outcome Measures

Days from start to first full oral feeding
first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects
Days from start to complete full oral feeding
complete full oral feeding : 2 days in a row without any adverse events The first successful day)
Overall transfer
% volume taken/volume prescribed
Proficiency
% volume taken at 5 min/volume prescribed
Rate of transfer
mL/min volume of milk consumed relative to the duration of the oral Feeding session
Volume loss
% volume of milk spilled from the lips as a percentage of the total milk transferred
Neonatal Oral Motor Assessment Scale (NOMAS)
comprehensive description of the infant's feeding patterns identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns
Length of hospital stay
Length of hospital stay
Bayley Scales of Infant and Toddler Development, Third Edition
an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children. cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication) subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals Total raw score range (min~max) : cognitive (0~91), receptive communication (0~49), expressive communication (0~48), fine motor (0~66), gross motor (0~72) Higher scores mean better outcomes
Korean version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
-a simple screening test for language development
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth edition.
An innovative measure of cognitive development and an intelligence test for preschoolers and young children Primary index scales> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==> Full scale IQ Ancillary index scales > vocabulary acquisition scaled score, composite score, percentile rank, CI Range of Full scale IQ : min (40) ~ max (160) Higher scores mean better outcomes.
Korean Developmental Screening Test
A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems Domains: gross motor, fine motor, language, cognition, sociality, self-care Score range of each domain : min (0) ~ max (24) Higher scores mean better outcomes.
Strengths and Difficulties Questionnaire
a brief behavioural screening questionnaire 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10) total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40) Lower scores mean better outcomes for the all scales except the prosocial scale
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
A comprehensive and widely used measure of behavioral and skill-based feeding problems It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors. Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not. Child an parent frequency scores : from the Likert scales (score range : min 35 ~ max 175) Child and parent problem scores : from the yes/no questions

Full Information

First Posted
July 23, 2015
Last Updated
May 23, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02508571
Brief Title
Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Official Title
The Effects of Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2020 (Actual)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is randomized controlled trial investigating the effects of direct swallowing training and oral sensorimotor stimulation in preterm infants on oral feeding performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn, Intervention Studies
Keywords
Infant, Premature, Intervention Studies, Bottle feeding

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
Allocation is concealed from all investigators, nurses, doctors, and parents, with the sole exception of the occupational therapists, who provided the interventions.
Allocation
Randomized
Enrollment
189 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Two 15-minute sessions of sham intervention/day, five days a week
Arm Title
DST group
Arm Type
Experimental
Arm Description
One session of DST and the other of sham intervention/day, five days a week
Arm Title
DST+OSMS group
Arm Type
Experimental
Arm Description
One session of DST and the other of OSMS/day, five days a week
Intervention Type
Other
Intervention Name(s)
Direct swallowing training (DST)
Intervention Description
The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Intervention Type
Other
Intervention Name(s)
Oral sensorimotor stimulation (OSMS)
Intervention Description
The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Intervention Type
Other
Intervention Name(s)
Sham intervention
Intervention Description
The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
Primary Outcome Measure Information:
Title
Days from start to independent oral feeding
Description
Days from start to independent oral feeding (independent oral feeding, 2 days in a row with no adverse events that do not self-resolve - The first successful day)
Time Frame
From date of starting oral feeding until the date of independent, full oral feeding, an expected average of 3 weeks
Secondary Outcome Measure Information:
Title
Days from start to first full oral feeding
Description
first full oral feeding : The first day that attain the full oral feeding regardless of feeding side effects
Time Frame
From date of starting oral feeding until the date of first full oral feeding, an expected average of 2 weeks
Title
Days from start to complete full oral feeding
Description
complete full oral feeding : 2 days in a row without any adverse events The first successful day)
Time Frame
From date of starting oral feeding until the date of complete oral full feeding, an expected average of 3-4weeks
Title
Overall transfer
Description
% volume taken/volume prescribed
Time Frame
Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Title
Proficiency
Description
% volume taken at 5 min/volume prescribed
Time Frame
Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Title
Rate of transfer
Description
mL/min volume of milk consumed relative to the duration of the oral Feeding session
Time Frame
Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Title
Volume loss
Description
% volume of milk spilled from the lips as a percentage of the total milk transferred
Time Frame
Total number of assessment : 3 times ( 1. starting oral feeding, 2. volume of oral feeding/total feeding volume x 100 = 50%, 3. volume of oral feeding/total feeding volume) x 100 = 100%
Title
Neonatal Oral Motor Assessment Scale (NOMAS)
Description
comprehensive description of the infant's feeding patterns identify normal oral-motor patterns and to differentiate disorganized from dysfunctional patterns
Time Frame
Total number of assessment : 2 times ( 1. 3-5 days after starting oral feeding, 2. within 3 days after stopping intervention)
Title
Length of hospital stay
Description
Length of hospital stay
Time Frame
From date of admission until the date of discharge, through study completion, expected average days of 3 month
Title
Bayley Scales of Infant and Toddler Development, Third Edition
Description
an individually administered instrument designed to assess the developmental functioning of infants, toddlers, and young children. cognitive scale, motor scale (gross motor, fine motor), language scale (receptive communication, expressive communication) subtest total raw scores & scaled scores / composite scores /percentile ranks/ confidence intervals Total raw score range (min~max) : cognitive (0~91), receptive communication (0~49), expressive communication (0~48), fine motor (0~66), gross motor (0~72) Higher scores mean better outcomes
Time Frame
Corrected age 18-24 months
Title
Korean version of MacArthur-Bates Communicative Development Inventories (K M-B CDI)
Description
-a simple screening test for language development
Time Frame
postnatal age 36±2 months
Title
Korean-Wechsler Preschool and Primary Scale of Intelligence (K-WPPSI)-Fourth edition.
Description
An innovative measure of cognitive development and an intelligence test for preschoolers and young children Primary index scales> verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed ==> Full scale IQ Ancillary index scales > vocabulary acquisition scaled score, composite score, percentile rank, CI Range of Full scale IQ : min (40) ~ max (160) Higher scores mean better outcomes.
Time Frame
aged 4:00~4:11 years
Title
Korean Developmental Screening Test
Description
A fill-up questionnaire to be answered by parents so as to determine who experience developmental problems Domains: gross motor, fine motor, language, cognition, sociality, self-care Score range of each domain : min (0) ~ max (24) Higher scores mean better outcomes.
Time Frame
postnatal age 48±3 months
Title
Strengths and Difficulties Questionnaire
Description
a brief behavioural screening questionnaire 5 subscales: Emotional problems scale, Conduct problems scale, Hyperactivity scale, Peer problems scale, Prosocial scale (score range of each scale : 0-10) total difficulties score : summing scores from all the scales except the prosocial scale (score range : 0-40) Lower scores mean better outcomes for the all scales except the prosocial scale
Time Frame
postnatal age 48±3 months
Title
Behavioral Pediatrics Feeding Assessment Scale (BPFAS)
Description
A comprehensive and widely used measure of behavioral and skill-based feeding problems It consists of 35 questions: 25 related to child eating, and 10 related to parent feeding behaviors. Parents answer each question on a five-point Likert scale, then indicate whether they perceive that behavior to be problematic or not. Child an parent frequency scores : from the Likert scales (score range : min 35 ~ max 175) Child and parent problem scores : from the yes/no questions
Time Frame
postnatal age 48±3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
31 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preterm infants : before 32+0 weeks gestation Infants who are receiving full tube feeding (more than 120 ml/kg/day) Infants who discontinue of nasal continuous positive airway pressure before postmenstrual age 33+0 weeks 'Feeders and growers' The parents of the subject voluntarily sign the informed consent Exclusion Criteria: Major congenital anomalies : face, central nervous system, gastrointestine, heart, etc Gastrointestinal complications Chronic medical complications : Intraventricular hemorrhage ≥ Grade III, periventricular leukomalacia, surgical necrotizing enterocolitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ee-kyung Kim
Organizational Affiliation
Seoun National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22404221
Citation
Lau C, Smith EO. Interventions to improve the oral feeding performance of preterm infants. Acta Paediatr. 2012 Jul;101(7):e269-74. doi: 10.1111/j.1651-2227.2012.02662.x. Epub 2012 Apr 5.
Results Reference
background
PubMed Identifier
12183719
Citation
Fucile S, Gisel E, Lau C. Oral stimulation accelerates the transition from tube to oral feeding in preterm infants. J Pediatr. 2002 Aug;141(2):230-6. doi: 10.1067/mpd.2002.125731. Erratum In: J Pediatr 2002 Nov;141(5):743.
Results Reference
background
PubMed Identifier
34281934
Citation
Heo JS, Kim EK, Kim SY, Song IG, Yoon YM, Cho H, Lee ES, Shin SH, Oh BM, Shin HI, Kim HS. Direct swallowing training and oral sensorimotor stimulation in preterm infants: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2022 Mar;107(2):166-173. doi: 10.1136/archdischild-2021-321945. Epub 2021 Jul 19.
Results Reference
derived

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Direct Swallowing Training and Oral Sensorimotor Stimulation in Preterm Infants

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